Hi.

No, just because it is a standard method it doesn't mean you don't need to validate it. It just means that you have access to more accuracy and precision data about it. You always MUST SHOW (validation) that you are able to accurately reproduce the method.

"Validation" of an analytical method is the set of studies you have to carry out when installing it to ensure its accuracy and precision. These studies may vary a bit from technique to technique, but will always include inter-day precision, intra-day precision, recovery, inter-laboratory accuracy tests, certified reference materials, and calibration of all instruments used in the measurements.

"Verification" of a method can have 2 meanings:

1 - Some people call verification to the routine quality control of an analytical method. Whenever you run a batch of samples, some replicas, recovery tests, control standards and blanks must be analysed for quality control.

2 - I've seen "verification" of a method being used with the meaning of a process by which a third party verifies that your validation is in accordance with the requirements for the method. For example, an audit under a quality management system (ISO 17025) implies a verification of your method.

Hope this helps!

Cheers!

I have posted a presentation in my profile based on MV in CRO. You may have a look.

Verification is basically to see whether your instrument and procedure generate correct reults. In other words, you are well aware with the process.

I agree with Mário Silva

Dear Shlomit Segev,

The difference between verification and full validation.

01. Verification :

The process of evaluating software to determine whether the products of a given development phase satisfy the conditions imposed at the start of that phase.

Verification is a static practice of verifying documents, design, code and program. It includes all the activities associated with producing high quality software: inspection, design analysis and specification analysis. It is a relatively objective process.

Verification will help to determine whether the software is of high quality, but it will not ensure that the system is useful. Verification is concerned with whether the system is well-engineered and error-free.

Methods of Verification : Static Testing

02. Validation :

The process of evaluating software during or at the end of the development process to determine whether it satisfies specified requirements.

Validation is the process of evaluating the final product to check whether the software meets the customer expectations and requirements. It is a dynamic mechanism of validating and testing the actual product.

Methods of Validation : Dynamic Testing

The difference between the Validation and Verification is largely to do with the role of specifications.

01. Verification is the process of checking that the software meets the specification.  

“Did I build what I need?”

02. Validation is the process of checking whether the specification captures the customer’s needs.

“Did I build what I said I would?”

I hope I have answered your question.

With Best Wishes,

Samir G. Pandya

Verification for pharmacopial method the only suggested parameters to do are :specificity ,accuracy , LOQ for related substances test , precision for dissolution instead of accuracy , system suitability

When using chromatographic pharmacopoeial method in practice, it is necessary to take into account the following:

1. In the case of using the pharmacopoeial method for dosage form, the full revalidation is always required due to the potential effect of the difference in excipients.

2. For impurity determination methods only the column specified in pharmacopoeia, should be taken. Even when replacing the column with the same type (for example С18 - С18) the specificity should be revalidated and the method should be verified.

"solving the equations right" and it is called verification.

Validation means" do we solve "the right equations"?

Thus verification tries to quantify the numerical errors and uncover programming bugs, whereas validation deals with the modelling errors.

"Validation of an analytical procedure is the process by which it is established, by laboratory studies, that the performance characteristics of the procedure meet the requirements for the intended analytical applications. Typical analytical performance characteristics that should be considered in the validation of the types of procedures described in this document are listed in Table …" (https://hmc.usp.org/sites/default/files/documents/HMC/GCs-Pdfs/c1225_1SUSP40.pdf)

"The verification process for compendial test procedures is the assessment of whether the procedure can be used for its intended purpose, under the actual conditions of use for a specified drug substance and/or drug product matrix" (https://hmc.usp.org/sites/default/files/documents/HMC/GCs-Pdfs/c1226.pdf).